CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 241 enrolled
Drug / intervention
Fluad Vaccine +1 moredrug
Likely dose
Fluad (MF59-adjuvanted inactivated influenza vaccine) or Fluzone High-Dose (high-dose inactivated influenza vaccine) as single dose; specific mg/dose not stated in trial recordAI-extracted
Key inclusion· 6
  • ✓Age 18–40 or ≥65 years at enrollment
  • ✓Generally healthy with no autoimmune or immunosuppressive conditions
  • ✓Stable preexisting disease allowed if not requiring significant therapy change or hospitalization for worsening in past 12 weeks
  • ✓Diabetes allowed if hemoglobin A1c <8.0 measured within past 6 months
Key exclusion· 10
  • ✕Known or suspected immunodeficiency or immunosuppressive therapy (systemic corticosteroids, cytotoxic agents); short-term steroids allowed if discontinued ≥30 days prior
  • ✕Serious chronic conditions: metastatic malignancy, severe COPD on supplemental oxygen, end-stage renal disease, clinically unstable cardiac disease
  • ✕Diabetes with A1c >8.0 or no A1c measurement within past 6 months
  • ✕Blood products or immunoglobulin within 6 months of enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03603509
NCT03603509Phase 4Completed
CompareCT.gov

Transcriptomic Signatures of Influenza Vaccine Responses

Mayo Clinic·interventional·Posted Jul 27, 2018·Updated May 16, 2023

In Brief

A Phase 4 clinical trial evaluating Fluad Vaccine and Fluzone High-Dose for Influenza. Completed, enrolled 241 participants across 1 site.

Detailed Summary

The purpose of this research study is to better understand the immune response to the Adjuvanted Subunit flu vaccine (MF59) and the High Dose flu vaccine (HDFlu) in people 65 years of age and older. The research team will be studying why immune response diminishes as people get older in both men and women. The ultimate goal is to understand how flu immunity develops after vaccination. This information may lead to the development of more effective flu vaccines in the future.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartAug 27, 2018
Primary CompletionJan 2, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.9 years ago

Interventions

Fluad Vaccinedrug

FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.

Fluzone High-Dosedrug

FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.